- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03747016
The Use of High-energy Digestible Food in Women Undergoing Caesarean Section
Study Overview
Status
Conditions
Detailed Description
This study is a prospective randomized controlled study to investigate the gastric emptying time of high energy digestible foods in delivery women, and the effect of high energy digestible food given before surgery on the comfort and metabolism of women undergoing Cesarean section.
In the first step, 60 women in delivery room are enrolled, who are full term singleton pregnancy subjects ranging 18 to 50 years old and fasting for more than 8 hours. They are randomly divided into three groups, 20 cases in each group.
The experimental group (Group E1) is treated with high energy digestible food 300ml, Group G1 is given 5% glucose injection 300ml and Group N1 is given normal saline 300ml. The gastric volume was determined by gastric antrum cross-sectional area (CSA) measured with ultrasonography before drinking and once every hour after drinking. Once CSA is less than 3.81 cm2, the time is recorded as gastric emptying time of the woman. The overall gastric emptying time of high energy digestible food is determined with the 90 percentile gastric emptying time of women drinking high energy digestible food.
The second step was to recruit 80 cases of full-term elective cesarean section. They were randomly divided into four groups, 20 cases in each group. The experimental group (Group E2) was given high energy digestible food 300ml before the time of gastric emptying found in the first step, Group G2 is given 5% glucose injection 300ml and Group N2 is given normal saline 300ml, while the control group (Group C2) was not given any diet. After admission to the operation room, the volume of the stomach was measured by ultrasound, and the differences of comfort, body temperature, shivering, blood glucose and postoperative anal exhaust time between the two groups were observed.
This study is going to investigate the gastric emptying time of high energy digestible foods in delivery women, and the effect of high energy digestible food on the comfort, body temperature and blood glucose of women undergoing Cesarean section, so as to provide a good basis for reducing the surgery stress in women undergoing Cesarean section.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China
- Recruiting
- Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
-
Contact:
- Qiwei Wu
- Phone Number: 13564621298
- Email: 13564621298@163.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA (American Society of Anesthesiologist) grade II, full term singleton pregnancy subjects aged 18 to 50 years old;
- subjects undergoing elective cesarean section under combined spinal epidural anesthesia;
- volunteered to participate in the study and signed informed consent.
Exclusion Criteria:
- related drug allergies or taboo;
- Severe cardiopulmonary disorders (New York Heart Association Classification III-IV, or left ventricular ejection fraction < 30%) and liver and kidney dysfunction (alanine aminotransferase exceeding the upper limit of normal value twice, creatinine exceeding the upper limit of normal value 1.5 times), alcoholism history;
- there are metabolic diseases such as gestational diabetes mellitus, or using drugs that affect metabolism;
- the subjects were unable to cooperate or to communicate;
- the subjects suffered from psychosocial diseases;
- participated in other clinical trials within one month;
- there is drug abuse.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High energy 2
In the second step, the experimental group (Group E2) was given high energy digestible food 300ml before the time of gastric emptying found in the first step before surgery.
|
The women undergoing Cesarean section are given high energy digestible food 300ml before surgery
Other Names:
|
Active Comparator: Glucose 2
In the second step, Group G2 is given 5% glucose injection 300ml before the time of gastric emptying found in the first step before surgery.
|
The women undergoing Cesarean section are given glucose injection 300ml before surgery
Other Names:
|
Placebo Comparator: Normal saline 2
In the second step, Group N2 is given normal saline 300ml before the time of gastric emptying found in the first step before surgery.
|
The women undergoing Cesarean section are given normal saline 300ml before surgery
Other Names:
|
No Intervention: Control 2
In the second step, the control group (Group C2) was not given any diet before surgery.
|
|
Experimental: High energy 1
In the first step,The experimental group (Group E1) is treated with high energy digestible food 300ml.
|
The women in delivery room are given high energy digestible food 300ml.
Other Names:
|
Active Comparator: Glucose1
In the first step, Group G1 is given 5% glucose injection 300ml
|
The women in delivery room are given glucose injection 300ml.
Other Names:
|
Placebo Comparator: Normal saline 1
In the first step, Group N1 is given normal saline 300ml.
|
The women in delivery room are given normal saline 300ml.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
body temperature
Time Frame: the time point when newborn delivers and 1 hour after surgery
|
Maternal tympanic temperature measured by infrared ear thermometer
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the time point when newborn delivers and 1 hour after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal comfort
Time Frame: up to 24 hours after surgery
|
Maternal comfort is measured by the women undergoing Cesarean section with visual analogy scale.
Respondents mark the location on the 10-centimeter line corresponding to the amount of comfort they experienced.
|
up to 24 hours after surgery
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Incidence and severity of shivering
Time Frame: up to 1 hour after surgery
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Incidence and severity of shivering is assessed with Wrench's Grade.
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up to 1 hour after surgery
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nausea and vomitting after surgery
Time Frame: up to 24 hours after surgery
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The severity of postoperative nausea and vomitting is assessed with CTCAE v4.0.
|
up to 24 hours after surgery
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flatus time
Time Frame: up to 48 hours after surgery
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The time point when anal exhaust restarts after surgery
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up to 48 hours after surgery
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pain after surgery
Time Frame: up to 48 hours after surgery
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Maternal pain is measured by the women undergoing Cesarean section with visual analogy scale.
Respondents mark the location on the 10-centimeter line corresponding to the amount of pain they experienced.
|
up to 48 hours after surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ERAS obstetric
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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